15 September 2017 - Recommendation based on extensive analytical, pharmacological, non–clinical & clinical data, which demonstrated similarity of Cyltezo/BI 695501 to Humira.

Boehringer Ingelheim today announced that the CHMP of the EMA has adopted a positive opinion for the Marketing Authorisation Application of Cyltezo (adalimumab biosimilar), to treat multiple chronic inflammatory diseases in adults and children. The decision of the European Commission on the approval is expected in the fourth quarter of 2017.

The marketing authorisation application for Cyltezo was based on a comprehensive data package supporting the biosimilarity of Cyltezo to Humira (adalimumab) based on analytical, pharmacological, non-clinical and clinical data, including results from the pivotal Phase III study VOLTAIRE-RA, which demonstrated clinical equivalence of BI 695501 to the reference product in people with moderate to severely active rheumatoid arthritis. The pivotal phase III study met its primary endpoint showing no clinically meaningful difference in efficacy between BI 695501 and Humira in terms of safety and immunogenicity.

Read Boehringer Ingelheim press release